The situation regarding medical cannabis is evolving, albeit slowly, in France. After a period of waiting, the decree authorizing theexperimentation of therapeutic cannabis in France has been published, followed by the order establishing the specifications. CBD.FR focuses on this in this article.
The recommendation for this experiment with therapeutic cannabis in France
Indeed, before addressing the decree itself, it is important to look back at previous recommendations, which culminated in the current authorization and specifications in the terms of reference.
In fact, cannabis is a narcotic in France. Consequently, its possession and use are prohibited by Law No. 70-1320 of December 31, 1970.However, Decree No. 2013-473 of June 5, 2013, amending the provisions of Article R. 5132-86 of the Public Health Code relating to the prohibition of operations involving cannabis or its derivatives, allows the marketing of cannabis-based medicines and its derivatives.
In this context, the aforementioned provision facilitated the emergence of two cannabis-based medications in France: SATIVEX and DRONABINOL (MARINOL). The former, a mixture of two cannabis extracts, received its authorization in 2014. Its primary purpose is to treat symptoms related to moderate to severe spasticity associated with multiple sclerosis, as a second-line treatment for adult patients. Unfortunately, difficulties in reaching an agreement on its price have hampered its commercialization in France.
The latter (DRONABINOL) has been available since 2003. Its indications are: neuropathic pain after failure of all treatments, nausea and vomiting in the context of cancer chemotherapy, and anorexia in HIV patients.
These two major varieties have brought to the forefront the issue of a possible experiment with medical cannabis in France. In this context, the ANSM (French National Agency for Medicines and Health Products Safety) created a temporary specialized scientific committee (CSST) in 2018 to conduct an " Evaluation of the relevance and feasibility of making medical cannabis available in France ." It should be noted that the two varieties mentioned above are not included in this assessment.
In December 2018, the CSST issued its conclusions. In fact, the Committee believes:
"that it is relevant to authorise the use of cannabis for therapeutic purposes for patients in certain clinical situations and in cases of insufficient relief or poor tolerance of available therapies, whether medicinal or not (and in particular of available cannabis or cannabinoid-based specialties).".
Furthermore, certain indications have been adopted. In this regard, these concern the use of medical cannabis for:
- pain that is refractory to available therapies (drug or otherwise);
- certain severe and drug-resistant forms of epilepsy;
- supportive care in oncology;
- palliative situations;
- painful spasticity of multiple sclerosis.
At the end of December 2018, the ANSM (French National Agency for Medicines and Health Products Safety) issued a favorable opinion on the CSST's (Scientific and Technical Committee for Medicines) conclusions. Consequently, it proposed that this use be tested first. The CSST then met again, studied the details of the trial, and consulted with stakeholders. The ANSM accepted the CSST's recommendations on the experimental phase on July 11, 2019.
That said, the next step following this recommendation is the publication of the decree authorizing theexperimentation of therapeutic cannabis in France, followed by the order establishing the specifications.
Regarding the decree authorizing the experimentation of therapeutic cannabis in France
In fact, it is dated October 7, 2020 and was published in the official journal on October 9, 2020. That said, what is its essence?
First, let's discuss the start date, the number of patients involved, and the duration. Themedical cannabis trial in France will begin no later than March 31, 2021. A total of 3,000 patients are involved. The trial will last for two years.
Next, what medications does the CSST recommend for theexperimentation of medical cannabis in France ? These are primarily:
- medicines made from dried cannabis flowers and full-spectrum extracts;
- immediate effect forms (sublingual and inhaled based on oiland dried flowers for vaporization);
- prolonged effect forms (oral forms such as oral solution or oil capsules )
Note that, in this regard, the CSST recommends the provision of 5 Tetrahydrocannabinol (THC)/Cannabidiol (CBD) ratios.
Finally, what about the recommended dosage for this experiment with medical cannabis in France? As VIDAL indicates, it:
(…) will have to be done by titration by the doctor until the minimum effective dose and/or adverse effects tolerable by the patient are obtained.
Furthermore, what are the other relevant specifications? We present them, point by point.
- The medications : are subject to an initial prescription by doctors and are provided free of charge by the companies participating in the experiment.
- The doctors : volunteers and trained working in reference structures that take care of the 5 therapeutic indications or clinical situations refractory to accessible treatments and selected for the experiment.
- Prescription renewal : can be carried out by any previously trained doctor (via the dedicated platform).
- Information : Patients included in the experiment are informed about the special precautions for using cannabis-based medications, possible side effects, contraindications and effects on driving vehicles or using certain machines at the time of prescription.
- The protocol : VIDAL describes it as follows:
The implementation schedule for the experimental phase will include six months of setup, six months of patient enrollment, six months of patient follow-up with the submission of an interim report, and six months of data analysis.
This evaluation will be conducted by a multidisciplinary scientific committee, including patient representatives. This committee will be responsible for analyzing the registry data, regularly monitoring safety data, and writing study reports.
In addition, it will work on developing specifications for suppliers of the medications used in the trial, creating training modules (for prescribers, dispensers, and patients), defining the registry content , and drafting a guide of recommendations for prescribers.
Documentation
Regarding the decree and the order
To obtain the decree of October 7, 2020, you can:
- Go to LEGIFRANCE.
To obtain the Order of October 16, 2020 setting out the specifications for cannabis-based medicines used during the experiment, you can:
- Go to LEGIFRANCE.
Regarding the specifications
Regarding the specifications, we provide you with several specific documents.
- Download the presentation of the specifications document created by Newsweed.
- Download the patient distribution presentation by Newsweed.
More documents
To explore this topic further, we suggest you:
- This report on the experimentation of therapeutic cannabis in France, published by the ANSM,
- This FAQ from the ANSM.
- Where and how can I get a prescription for medical cannabis in France?
Co-founder of CBD.fr
Julien Cordobes is the editor of CBD.fr. Born in 1978 in the Paris region, he first trained in e-commerce before turning to natural health approaches, a dual perspective that now structures his way of writing about cannabidiol: reading the scientific literature as it is, without hardening the conclusions, and presenting it in a language that everyone understands.
He discovered CBD at a time when the French market was developing faster than the information available to it. He acquired CBD.fr in 2022 and then took on editorial responsibility for the blog. Since then, he has published numerous articles covering the daily use of CBD, the interpretation of laboratory analyses, the evolution of the legal framework, and precautions for use.
